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Month: April 2025

Revolution Medicines Presents Initial Data from Zoldonrasib (RMC-9805) Study in Patients with KRAS G12D Mutant Non-Small Cell Lung Cancer at the 2025 AACR Annual Meeting

Zoldonrasib, a RAS(ON) G12D-selective inhibitor, demonstrated acceptable tolerability and encouraging initial antitumor activity in patients with previously treated KRAS G12D mutant non-small cell lung cancer REDWOOD CITY, Calif., April 27, 2025 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced new clinical data for zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, as monotherapy in patients with KRAS G12D mutant non-small cell lung cancer (NSCLC). Results were highlighted in the official press program at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, and will be featured in a late-breaking oral presentation on April 27, 2025, at 5:00 p.m. Central...

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SpringWorks Therapeutics Announces Expected CHMP Opinion in Q2 2025 for Nirogacestat for the Treatment of Adults with Desmoid Tumors in the European Union

STAMFORD, Conn., April 27, 2025 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company anticipates the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) will adopt an opinion on the marketing authorization application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of adults with desmoid tumors in the second quarter of 2025. About SpringWorks Therapeutics SpringWorks is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with severe rare diseases and cancer. We developed and are commercializing OGSIVEO® (nirogacestat) as the first and only FDA-approved medicine for adults with desmoid tumors...

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Risk Strategies acquires GMC Advisors, LLC

Texas-based commercial lines agency adds to construction, manufacturing, and energy industry expertise BOSTON, April 27, 2025 (GLOBE NEWSWIRE) — Risk Strategies, a leading North American specialty insurance brokerage, risk management and consulting firm, announced today that it has acquired GMC Advisors, LLC., based in Houston. Terms of the deal were not disclosed. Headed by owner Greg Chubon, GMC Advisors is a specialist in commercial lines insurance products, with a focus on the construction and manufacturing industries, as well as companies in the energy sector. Founded in 2003, the firm has built a record of consistent growth propelled by specialty knowledge and a focus on helping middle-market companies in target industries. “It is great to add such deep industry expertise to our West Region as we continue to build out our...

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UPDATE — Relmada Therapeutics To Present NDV-01 Data at AUA2025

Data to be presented in Clinical Trials in Progress Session on Monday, April 28, 2025 CORAL GABLES, Fla., April 27, 2025 (GLOBE NEWSWIRE) — Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a clinical-stage biotechnology company, today announced the presentation of an abstract at the American Urology Association (AUA2025), taking place from April 26-29th in Las Vegas.Abstract OverviewAbstract Title:   Prospective Open Label Study to Evaluate the Safety and Efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Risk NMIBCSession:   Clinical Trials in Progress: Bladder CancerLocation:   Hall C, The Square, Learning LabPresentation Date:   April 28, 2025Presentation Time   10:04 AM PT to 10:12 AM PT     About NDV-01NDV-01 is an investigational, innovative...

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CG Oncology Announces Best-in-Disease Durability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene Grenadenorepvec at the American Urological Association Annual Meeting

– Robust 24-month complete response rate of 42.3% by K-M for cretostimogene monotherapy in BOND-003 Cohort C – – 58.3% of patients showed durable complete responses by K-M at 24 months – – 97.3% of all treated patients remained free from progression to MIBC at 24 months– – 91.6% of responders remained cystectomy-free at 24 months – – No Grade 3 or greater treatment-related adverse events or deaths reported – – Strong initial Cohort P data reported 90.5% high-grade recurrence-free survival at 3 and 9 months by K-M – – Company will host a conference call and webcast at 8 a.m. EDT on Monday, April 28, 2025 – IRVINE, Calif., April 26, 2025 (GLOBE NEWSWIRE) — CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential...

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IO Biotech Showcases Scientific Leadership Through Cancer Vaccines Educational Session at the American Association for Cancer Research (AACR) Annual Meeting 2025

NEW YORK, April 26, 2025 (GLOBE NEWSWIRE) — IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announced that one of its scientific co-founders, Mads Hald Andersen, DMSc, PhD, Director of the National Center for Cancer Immune Therapy (CCIT-DK), chaired and presented at an educational session on cancer vaccines at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The session brought together leading oncology scientists and explored the latest advancements in cancer vaccine research, from preclinical innovation to clinical implementation, providing perspective on the future of cancer vaccines and their potential to reshape cancer immunotherapy (session #ED59). The session included presentations of key developments...

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Valneva Provides Update on Recommendation for Use of Its Chikungunya Vaccine by French Authorities

Saint Herblain (France), April 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that France’s national public health agency, the Haute Autorité de Santé (HAS), has updated its recommendation for use of Valneva’s single-dose chikungunya vaccine IXCHIQ® for the prevention of disease caused by the chikungunya virus (CHIKV) following reports of serious adverse events (SAEs) in elderly people with comorbidities during the ongoing vaccination campaign in La Reunion and Mayotte. Valneva has been responding to the French government’s call for vaccine supply of IXCHIQ® in La Reunion1 as the island is going through a major chikungunya outbreak with ~ 40,000 confirmed cases since the beginning of 20252. The authorities initially prioritized vaccination of adults aged 65 and over, especially...

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Protara Therapeutics Announces Positive Interim Results Demonstrating Durable Responses in the Ongoing Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC

TARA-002 demonstrates 100% complete response rate at any time and 67% 12-month landmark complete response rate in BCG-Unresponsive patients TARA-002 demonstrates 76% complete response rate at any time and 43% 12-month landmark complete response rate in BCG-Naïve patients Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events On track to present updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 Company to host conference call and webcast on Monday, April 28, 2025, at 8:30 a.m. ETNEW YORK, April 26, 2025 (GLOBE NEWSWIRE) — Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced updated results from its ongoing Phase...

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A.I.S. Resources Closes Non-Brokered Private Placement

VANCOUVER, British Columbia, April 25, 2025 (GLOBE NEWSWIRE) — A.I.S. Resources Limited (TSXV: AIS, OTC- PINK: AISSF) (“AIS” or the “Company”) announces the Company has closed its non-brokered private placement of 1,232,417 units (“Units”) at a price of $0.035 per unit for gross proceeds of $43,135 (the “Private Placement”). Each Private Placement Unit consists of one common share and one transferable share purchase warrant. Each warrant will entitle the holder thereof to purchase one additional common share for a period of 2 years from the closing date of the offering at a price of $0.05 per common share. Closing of the Private Placement is subject to final acceptance by the TSX Venture Exchange. All securities issued in connection with the Private Placement will be subject to a four-month hold period from the closing date under...

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Celularity Receives Nasdaq Notice Regarding Non-Payment of Nasdaq Fees

FLORHAM PARK, N.J., April 25, 2025 (GLOBE NEWSWIRE) — Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a cellular and regenerative medicine company, today announced that Nasdaq has notified the Company that it has not paid certain fees required by Listing Rule 5250(f) and accordingly the Company will be delisted unless it appeals this determination. The Company’s past due fee balance totaled $70,000. On April 25, 2025, the Company paid in full the fee balance owed to Nasdaq. Additionally, on April 16, 2024, Nasdaq notified the Company that it is delinquent in filing its Form 10-K for the year ended December 31, 2024, and therefore, does not comply with Listing Rule 5250(c)(1). Nasdaq requested the Company to provide a plan of compliance. However, pursuant to Listing Rule 5810(d)(2), this delinquency now serves as...

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